Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122446492 | 12244649 | 2 | F | 2014 | 20160805 | 20160407 | 20160811 | EXP | US-ROCHE-1736113 | ROCHE | 0.00 | M | Y | 0.00000 | 20160811 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122446492 | 12244649 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Unknown | 6 MONTH INFUSION AS PART OF CFL REGIMEN | 103705 | ||||||||||
| 122446492 | 12244649 | 2 | SS | Mefloquine | MEFLOQUINE | 1 | Unknown | U | 0 | ||||||||||
| 122446492 | 12244649 | 3 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 0 | |||||||||||
| 122446492 | 12244649 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122446492 | 12244649 | 1 | Chronic lymphocytic leukaemia |
| 122446492 | 12244649 | 2 | Product used for unknown indication |
| 122446492 | 12244649 | 3 | Chronic lymphocytic leukaemia |
| 122446492 | 12244649 | 4 | Chronic lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122446492 | 12244649 | OT |
| 122446492 | 12244649 | DS |
| 122446492 | 12244649 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122446492 | 12244649 | Asthenia | |
| 122446492 | 12244649 | Autoimmune thyroiditis | |
| 122446492 | 12244649 | Blindness cortical | |
| 122446492 | 12244649 | Central nervous system lesion | |
| 122446492 | 12244649 | Coma | |
| 122446492 | 12244649 | Fatigue | |
| 122446492 | 12244649 | Foreign body sensation in eyes | |
| 122446492 | 12244649 | Lethargy | |
| 122446492 | 12244649 | Nasopharyngitis | |
| 122446492 | 12244649 | Progressive multifocal leukoencephalopathy | |
| 122446492 | 12244649 | Seizure | |
| 122446492 | 12244649 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 122446492 | 12244649 | 1 | 2012 | 2013 | 0 | |
| 122446492 | 12244649 | 3 | 2012 | 2013 | 0 | |
| 122446492 | 12244649 | 4 | 2012 | 2013 | 0 |